Controlled Trial of ABELADRUG200 in Closed, Severe Head Injury
| Status: | Completed |
|---|---|
| Conditions: | Hospital, Neurology |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 16 - 70 |
| Updated: | 4/2/2016 |
| Start Date: | October 2010 |
| End Date: | December 2011 |
Phase 1/2 Multicenter, Randomized, Controlled Trial of ABELADRUG200 in Closed, Severe Head Injury
This is a randomized, controlled clinical trial at three sites to determine the safety and
preliminary efficacy of the study drug to treat severe head trauma (GCS 4-8). It is
hypothesized that the drug may lower pressure in the brain, reduce mortality and the patient
may have improved neurological function following treatment.
preliminary efficacy of the study drug to treat severe head trauma (GCS 4-8). It is
hypothesized that the drug may lower pressure in the brain, reduce mortality and the patient
may have improved neurological function following treatment.
Inclusion Criteria:
- Diagnosis TBI
- GCS 4-8
- Age 16-70
Exclusion Criteria:
- Multiple trauma resulting in shock
- Bilateral absent pupil response
- Time from injury > 6 hours
- Brain tumor or mass effect secondary to hemorrhage or brain surgery
- Pregnancy
- Confounding condition or injury
- Spinal cord injury
- Sustained high blood pressure or arterial oxygen saturation
We found this trial at
3
sites
1 Boston Medical Center Place
Boston, Massachusetts 02118
Boston, Massachusetts 02118
617.638.8000
Boston University Medical Center Boston Medical Center is an extraordinary community of health care providers...
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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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University of California, Irvine Since 1965, the University of California, Irvine has combined the strengths...
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